Nosocomial Pneumonia (NP) Clinical Trial
— RECOMMENDOfficial title:
Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.
| Verified date | September 2017 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study
| Status | Completed |
| Enrollment | 1322 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: ICF to be obtained (refer slides 26-30) Adult (=18 years) patients Patients with a diagnosis of at least one of the three conditions hospitalised during the period July 1, 2013 to June 30, 2014 Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP Exclusion Criteria: The patient participated in a clinical trial during the patient selection period (01-Jul-2013 to 30-Jun-2014) or during the follow-up period* For patients diagnosed with cUTI: The patient has a diagnosis of hospital acquired or healthcare associated cUTI with concomitant presence of Fungal UTI with colony count > 10^3/mL |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Research Site | Belo Horizonte | |
| Brazil | Research Site | Campinas | |
| Brazil | Research Site | Porto Alegre | |
| France | Research Site | Argenteuil | |
| France | Research Site | Bordeaux Cedex | |
| France | Research Site | Creteil cedex | |
| France | Research Site | Limoges cedex | |
| France | Research Site | Lyon Cedex 03 | |
| France | Research Site | Nantes Cedex 1 | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Patras | |
| Greece | Research Site | Thessaloniki | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Monza | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Vicenza | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Sestroretsk, St. Petersburg | |
| Spain | Research Site | Badalona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Oviedo | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Terrassa |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Brazil, France, Greece, Italy, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP | Evaluate failure or success of the initial antibiotic treatment following cUTI, cIAI and NP diagnosis. Initial antibiotic therapy is defined as all antibiotic agents received during the 48 hours post initiation of antibiotic therapy - The primary outcome measure will be assessed from the antibiotic initiation date until end of follow-up defined by in-hospital with symptom resolution, in-hospital without symptom resolution, discharged to home, discharged to other health care facility, readmission within 30 days for same infection, readmission within 30 days post discharge with other diagnosis, death during hospital stay, death post discharge within 30 days. | 12 months | |
| Secondary | To identify potential risk factors related to outcomes of initial antibiotic treatment of hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP | Assess risk factors related to the primary outcome measure. Covariates considered in the risk assessment will include: site characteristics, patient characteristics, secondary infections, prior medical history and comorbidity burden, hospitalization characteristics, pathogen characteristics, co-medications - The listed covariates will be assessed at baseline (i.e., at index hospitalization date), during the hospital stay and the 30-day period post discharge date. | 12 months | |
| Secondary | To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome | Assess health care utilization among patients with cUTI, cIAI and NP. Variables assessed to address this will include - hospital length of stay, ICU length of stay, number of surgical procedures, number of outpatient visits, days on antibiotic therapy, number of readmission during follow-up - The listed measures will be assessed during the hospital stay and during the 30-day period post discharge date. | 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01808092 -
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
|
Phase 3 |